Cervical spine protection apparatus and methods of use

ABSTRACT

The invention is directed to a cervical spine protection apparatus one or more composite bands attached to provide restraint of one or more motions of the cervical spine of a wearer. The apparatus is designed to protect a wearer from incurring cervical spinal injuries, and/or to reduce the severity of cervical spine injuries without substantially compromising the normal functional range of motion of the wearer&#39;s cervical spine.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention is directed to a cervical spine protection apparatus andmethods for use thereof. The invention may be useful for stabilizing thespine, particularly by facilitating the rehabilitation of or preventingand/or minimizing the occurrence and/or severity of spinal injuries,particularly cervical spine injuries.

2. Description of the Related Technology

High impact sports pose a substantial risk for head and spinal injuries.During a typical game of high school tackle football, about 40.5 headimpacts occur per hour, and about 24.4 head impacts occur per hourduring a typical game of high school hockey. Studies of helmet-to-helmetcollisions in the National Football League (NFL) using hybrid IIIdummies found that during collision, an athlete's head experiences achange in velocity of about 7.2±18 m/s, a translational acceleration ofabout 94.3±27.5 g and a rotational acceleration of about 6432±1813 r/s²during impact. Although helmets offer some degree of protection for thehead, they do not adequately safeguard the wearer from traumatic spinalinjuries, particularly cervical spine injuries. To the contrary, theNational Football Head and Neck Injury Registry concluded that helmetscan increase the risk of neck injuries when athletes use the helmet as aweapon. For example, practices such as “spearing” can induce axial loadtear drop fracture that may cause a wide range of neurologicaldisorders, including quadriplegia. During 1945-2004, 497 deaths werecaused by playing tackle football in the United States, 16% of whichwere attributed to spinal cord injuries; the annual incidence rate ofpermanent cervical spinal cord injuries was about 0.55 per 100,000 amongtackle football players.

In general, injuries to the cervical spine may occur when impact orinertial forces acting on the head are large enough to deform theunderlying connective tissues beyond their tolerance limits. When placedunder extreme loading and functional demands induced by high impactsports, contortions of the soft tissue allow the cervical spine toassume injurious positions. The primary factors that contribute to neckinjury are high torque jolts, the proximity of the neck to theanatomical joint limits, muscular fatigue and insufficiency, and theproperties of the head mounted load. For example, cervical cordneurapraxia, which causes temporary paralysis as well as a radiatingburning pain, numbness or tingling in the arm, is a common cervicalspine injury incurred during high impact sports. Caused by tractioninjury to the brachial plexus, percussive injury to the upper trunkand/or nerve compression when the neck undergoes a combination ofhyperextension and ipsilateral lateral rotation, cervical cordneurapraxia has a high incidence rate of 7 per 10,000 footballparticipants and a high recurrence rate of about 56%. About 65% ofcollege football players sustain at least one cervical cord neurapraxiainjury during their college careers.

The risk of traumatic cervical spine injuries, such as cervical cordneurapraxia, is even higher in children and adolescents than adults. Dueto the slower development of the cervical spine and the surroundingmusculature relative to the anatomical development of the head, childrenand adolescents are more prone to cervical spine injuries. Additionally,the specific biomechanical characteristics of pediatric cervical spinesincrease the likelihood of incurring severe neurological damage.

Despite the overwhelming documented epidemiological evidence of the highincidence rate of cervical spine injuries caused by high impact sports,no apparatus currently exists to protect a user from incurring suchinjuries. Conventional neck protection devices, such as the cowboycollar, bullock collar, kerr collar and neck roll, are generallyineffective in protecting the wearer from a wide range of loadingsituations and neck injuries experienced by different players, such asquarterbacks and linemen, during football. Notably, these devices do notmeet the performance requirements nor mitigate the risks associated withthe various different positions in football. Furthermore, there is nomeans for customizing the device to the preference, physiologicaldimensions and biomechanics, or intended use of a wearer. Of thesedevices, experiments have shown that the cowboy collar is the onlyapparatus that has been found to be partially effective againsthyper-extension of the neck. None of these devices, however, wereeffective in preventing other forms of forced movement, such as lateralbending or axial rotation. Furthermore, these devices tend to be bulky,substantially limit the natural range of motion of an athlete's head andinterfere with athletic performance.

Additionally, neck exercisers and protectors that include conventionalspring elements, such as that disclosed in U.S. Pat. No. 4,219,193, andhead stabilizing systems incorporating hydraulic pistons, such as thatdisclosed in U.S. Pat. No. 6,968,576, are also inadequate in protectingagainst, or rehabilitating cervical spine injuries. The conventionalspring and hydraulic mechanism of these devices fails to provideadequate resistance at the extreme ranges of motion of the cervicalspine to prevent injury and also substantially interfere with andinhibit the wearer's range of motion. Additionally, the arrangement ofthe springs and dampening mechanisms of these patents are inadequate forprotecting a wearer from a wide range of cervical spine injuries.

Therefore there is a need to develop a suitable apparatus capable ofreducing the risk of a wide variety of cervical spine injuries bydynamically limiting the motion of the cervical spine to a functionaland non-injurious range of motion without substantially limiting thewearer's normal range of motion.

SUMMARY OF THE INVENTION

The invention relates to a novel spine protection apparatus. In a firstaspect, the apparatus includes a composite band having an elastic bandwith a modulus of elasticity of from about 20 psi to about 30,000 psiattached to a substantially non-extendable band with a modulus ofelasticity of from about 400,000 psi to about 7,500,000 psi, whereinwhen the composite band is at rest, there is sufficient slack in thesubstantially non-extendable band to permit the elastic band to stretcha distance which defines a range of motion for a wearer of saidcomposite band.

The invention is also directed to a method for spinal stabilizationinvolving the steps of: providing at least one composite band having anelastic band with a modulus of elasticity of from about 20 psi to about30,000 psi attached to a substantially non-extendable band with amodulus of elasticity of from about 400,000 psi to about 7,500,000 psi;attaching the composite band to first and second attachment structureslocated at different positions along a spine in a manner whereby whenthe composite band is at rest, there is sufficient slack in thesubstantially non-extendable band to permit the elastic band to stretcha distance which defines a range of motion along a longitudinal axis ofthe elastic band for a wearer of the composite band.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1(a) is a sagittal view of an exemplary embodiment of theinvention, wherein a user's head is in a neutral position.

FIG. 1(b) is a posterior view of the embodiment of FIG. 1, wherein theuser's head is in a neutral position.

FIG. 1(c) is a perspective view of the embodiment of FIG. 1, wherein theuser's cervical spine is flexed.

FIG. 1(d) is a side view of the embodiment of FIG. 1, wherein the user'scervical spine is extended.

FIG. 1(e) is a rear view of the embodiment of FIG. 1, wherein the user'scervical spine is bent laterally.

FIG. 1(f) is a perspective view of the embodiment of FIG. 1, wherein theuser's cervical spine is rotated about its axis.

FIG. 2(a) is a perspective cross-sectional view of an exemplarycomposite band of the invention.

FIG. 2(b) is a lateral cross-sectional view of the exemplary compositeband of FIG. 2(a).

FIG. 2(c) is a perspective cross-sectional view of another exemplarycomposite band of the invention having a cylindrical configuration.

FIG. 2(d) is a longitudinal cross-sectional view of the exemplarycomposite band of FIG. 2(c). FIG. 3(a) shows a helmet and a brace of theinvention showing acceleration, velocity and displacement sensorsmounted thereon.

FIG. 3(b) shows an exemplary embodiment of the invention as well asacceleration, velocity and displacement sensors mounted on the wearerfor testing the invention.

FIG. 4(a) is a schematic diagram of the Neck Flexible Tester (NFT)system for measuring the biomechanical properties of the cervical spineunder quasi-static conditions.

FIG. 4(b) is a photograph of the NFT measuring the cervical spinebiomechanical properties of an individual wearing an exemplary cervicalspine protection apparatus of the present invention.

FIG. 5 is a graph of the passive and active range of motion of anindividual who was unprotected, wearing football gear and the sameindividual wearing both football gear and an exemplary cervical spineprotection apparatus of the present invention.

FIG. 6 is graph of the amplitude distribution as a function of distancefor the positions of the cervical spine in the sagittal plane for anindividual running on a treadmill who was unprotected, wearing footballgear, and the same individual wearing both football gear and anexemplary cervical spine protection apparatus of the present invention;mean values are represented by vertical lines.

FIG. 7(a) is a graph of power spectral density as a function offrequency for an individual who was unprotected, wearing football gear,and the same individual wearing both football gear and an exemplarycervical spine protection apparatus of the present invention.

FIG. 7(b) is a graph of the amplitude distribution of the linearacceleration of an individual's trunk along the x-axis from theposterior to anterior for an individual who was unprotected, wearingfootball gear, and the same individual wearing both football gear and anexemplary cervical spine protection apparatus of the present invention.

FIG. 8 is a graph of the amplitude distribution of the cervical spinepitch velocity for an individual who was unprotected, wearing footballgear, and the same individual wearing both football gear and anexemplary cervical spine protection apparatus of the present invention.

FIG. 9(a) is a schematic diagram of a hybrid III dummy representing a 6year old male child with no cervical spine protection.

FIG. 9(b) is a schematic diagram of a hybrid III dummy representing a 6year old male child wearing football gear.

FIG. 9(c) is a schematic diagram of a hybrid III dummy representing a 6year old male child wearing football gear and an exemplary cervicalspine protection apparatus of the present invention.

FIG. 9(d) is a schematic diagram of a hybrid III dummy representing anadult male with no cervical spine protection.

FIG. 9(e) is a schematic diagram of a hybrid III dummy representing anadult male wearing football gear.

FIG. 9(f) is a schematic diagram of a hybrid III dummy representing anadult male wearing football gear and an exemplary cervical spineprotection apparatus of the present invention.

FIG. 10(a) is a schematic showing the effect of on the head and cervicalspine of an adult male that is unprotected, wearing football gear andwearing both football gear and an exemplary cervical spine protectionapparatus of the present invention at the start of flexion.

FIG. 10(b) is a schematic showing the effect of maximum flexion on thehead and cervical spine of an adult male that is unprotected, wearingfootball gear and the same individual wearing both football gear and anexemplary cervical spine protection apparatus of the present invention.

FIG. 11 is a graph of load as a function of strain for an exemplarycomposite band of the invention showing the behavior of the compositeband at slow and fast loading rates.

FIG. 12(a) is a side view of a brace before attaching the compositebands of an exemplary cervical spine protection apparatus.

FIG. 12(b) is a side view of an exemplary cervical spine protectionapparatus after attaching the composite bands.

FIG. 12(c) is a magnetic resonance image showing an individual's head ina flexed position without the cervical spine protection apparatus of theinvention.

FIG. 12(d) is a magnetic resonance image showing an individual's head ina neutral position when the individual is wearing an exemplary cervicalspine protection apparatus of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

For illustrative purposes, the principles of the present invention aredescribed by referencing various exemplary embodiments. Although certainembodiments of the invention are specifically described herein, one ofordinary skill in the art will readily recognize that the sameprinciples are equally applicable to, and can be employed in othersystems and methods. Before explaining the disclosed embodiments of thepresent invention in detail, it is to be understood that the inventionis not limited in its application to the details of any particularembodiment shown. Additionally, the terminology used herein is for thepurpose of description and not of limitation. Furthermore, althoughcertain methods are described with reference to steps that are presentedherein in a certain order, in many instances, these steps may beperformed in any order as may be appreciated by one skilled in the art;the novel method is therefore not limited to the particular arrangementof steps disclosed herein.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural references unless thecontext clearly dictates otherwise. Thus, for example, reference to “aspring” may include a plurality of springs and equivalents thereof knownto those skilled in the art, and so forth. As well, the terms “a” (or“an”), “one or more” and “at least one” can be used interchangeablyherein. It is also to be noted that the terms “comprising”, “including”,“composed of” and “having” can be used interchangeably.

The present invention is directed to a novel spinal protection apparatusand methods for spinal stabilization. In an exemplary embodiment, theinvention may substantially facilitate the rehabilitation of or preventand/or minimize the risk of incurring and/or severity of a spinalinjury, particularly a cervical spine injury, by eliminating orminimizing the risk of injury due to hyperextension, rotationalhyperextension, flexion, lateral bending and other potentially injuriousspinal movements. Cervical spinal protection apparatus 100 of thepresent invention includes one or more composite bands 5 and functionsto restrain a user's head from assuming an injurious position. Apparatus100 may be attached between one or more upper attachment structures 2that may be operatively associated with a wearer's head, such as with aportion of a helmet 1, and one or more lower attachment structures 4,such as may be associated with a brace 3 or platform 7 that may beoperatively associated with a lower region of the wearer's body.Apparatus 100 of the present invention may be used to protect thecervical spine from injury due to a variety of impact and inertialforces without substantially interfering with the wearer's normal rangeof motion. It is envisioned that apparatus 100 may be particularlysuitable for use as a physical therapy device to facilitate cervicalspine rehabilitation or as safety equipment, such as protective athleticgear, protective construction gear, protective mining gear, etc.

Apparatus 100 may be attached to any one or more upper attachmentstructures 2 operatively associated with the head of a wearer. Anexemplary upper attachment structure 2 may be all or a portion of anyhead gear or structure suitable for securing apparatus 100 to the headof a wearer. In an exemplary embodiment, upper attachment structure 2may be a portion of or attached to a helmet 1, which may be any suitablehead covering that partially or completely covers a user's head. Helmet1 may have a closed and continuous structure that encloses a user'shead, an open framework that exposes one or more portions of the user'shead or any combination thereof. Additionally, helmet 1 may beconstructed from any material suitable for the intended use, includingfabrics, metals, ceramics, polymers, resins, or combinations thereof.Depending upon the application, helmet 1 may be constructed to have asubstantially hard or soft outer and/or inner shell. Helmet 1 may alsoinclude one or more conventional adjustment mechanisms for ensuring thathelmet 1 is adequately secured to a user's head, such as straps, bands,snaps, or other fasteners. Exemplary helmets 1 may include athleticheadgear for sports and recreational activities, such as footballhelmets, hockey helmets, baseball helmets, biking helmets, mountainclimbing helmets, skiing helmets, skateboarding helmets, and motorcyclehelmets; protective hard hats; protective mining hats; conventionalfabric caps; visors; etc.

Apparatus 100 may also be attached to one or more lower attachmentstructures 4 operatively associated with a region of the user's bodylower than the head. In an exemplary embodiment, lower attachmentstructure 4 may be attached to or provided by one or more braces 3.Brace 3 may have any structure or configuration suitable for providingor attaching one or more substantially fixed attachment structures, suchas platforms 7. In an exemplary embodiment, brace 3 may be worn about auser's neck and/or torso, such as the shoulders, back, waist orcombinations thereof. Brace 3 may include one or more conventionaladjustment mechanisms for ensuring that brace 3 is secured to the user'sbody, such as straps, bands, snaps, or other fasteners. Exemplary braces3 may include back braces, neck braces, shoulder pads, shoulder padsbridged with a back panel and/or neck rest, or combinations thereof.

Optionally, the fixed attachment structures may be provided by orassociated with one or more platforms 7 that are integrally or removablyattached to brace 3. Each platform 7 may have any suitable shape,dimension or configuration for providing the required fixed attachmentstructures or allowing attachment of suitable attachment structures. Asshown in the exemplary embodiment of FIGS. 1(a)-1(f), platform 7 has asubstantially planar posterior surface or flange for engaging compositebands 5. Platform 7 may further encircle at least a portion of theuser's neck, such as a left side of the neck, posterior region of theneck, right side of the neck or combinations thereof. Platform 7 mayoptionally further include an upwardly extending flap or collar that mayoffer further support and protection to the user's cervical spine.

As shown in FIGS. 1(a)-1(f), apparatus 100 includes one or morecomposite bands 5 that connect between an upper attachment structure 2,such as a portion of helmet 1, to a lower attachment structure 4, suchas a portion of brace 3 and/or platform 7. Each composite band 5 isdesigned to provide non-linear variable flexibility that is dependentupon variations in loading rates As shown in FIGS. 2(a)-2(b), in oneexemplary embodiment, composite band 5 is a visco-hyperelastic compositeband which includes one or more elastic bands 9 having a low modulus ofelasticity and one or more substantially non-extendable bands 11 havinga high modulus of elasticity that attaches to one another using anyconventional fastening means, such as by stitching, adhesive, heatfusion or combinations thereof. Bands 9, 11 may be attached to oneanother either partially or along the entire lengths of bands 9, 11 toform an integral structure. Elastic band 9 may be constructed from anyelastic or spring like material that is suitable for providing thedesired elasticity of band 9, and substantially non-extendable band 11may be constructed from any substantially non-extendable and/ornon-stretchable material.

In an exemplary embodiment, elastic band 9 may be constructed from oneor more elastic fabrics or polymers, such as rubber or nylon, elasticfabrics including Kevlar™ fibers, a spring such as a metal spring, orcombinations thereof. The elastic fabrics are preferably embedded in theelastic band in a crimped pattern to provide the desired elasticproperties. Elastic band 9 may have a modulus of elasticity of about 20psi to about 30,000 psi.

Exemplary materials for constructing substantially non-extendable band11 may include one or more substantially non-extendable fabrics orpolymers, such as stiff canvas, a spring such as a metal spring orcombinations thereof. Substantially non-extendable band 11 may have amodulus of elasticity of about 400,000 psi to about 7,500,000 psi.

Elastic band 9 and substantially non-extendable band 11 may have anyconfiguration suitable for enabling the visco-hyperelastic flexibilityand extension of composite band 5. For example, elastic band 9 and/orsubstantially non-extendable band 11 may have a coiled spring structure,leaf spring structure, planar band structure, undulating wave structureor any suitable combination thereof. In the exemplary embodiment shownin FIGS. 2(a)-2(b), elastic band 9 may be configured as a flexibleplaner band, and substantially non-extendable band 11 may have a wavyconfiguration.

FIGS. 2(c)-2(d) show another exemplary embodiment, wherein elastic band9 and substantially non-extendable band 11 together form a cylindricalconfiguration. Optionally, elastic band 9 and substantiallynon-extendable band 11 may be surrounded by a sleeve 13 that may befabricated from any material that accommodates and does not interferewith the movement or flexibility of elastic band 9 and substantiallynon-extendable band 11.

Optionally, as shown in FIG. 2(a)-2(d), the area between elastic band 9and substantially non-extendable band 11 may be partially or completelyfilled with a viscous material 15 suitable for facilitating dampening ofthe movement of the visco-hyperelastic composite band 5. Exemplaryviscous materials may be any gel having a viscosity similar to oil,grease or polymers, such as nylon. Preferably, the viscous material hasa viscosity of about 150 cP to about 100,000 cP.

In an exemplary embodiment, viscous material 15 may maybe containedbetween elastic band 9 and substantially non-extendable band 11 byvirtue of the attachment between these bands 9, 11. In one embodiment,elastic band 9 and substantially non-extendable band 11 may be attachedto one another along the perimeters of the bands and viscous material 15may freely flow therebetween. In another embodiment, elastic band 9 andsubstantially non-extendable band 11 may be attached to one anotheralong the perimeter of the bands and between each wave of thesubstantially non-extendable band 11 so as to form a plurality ofpockets therebetween that may individually contain viscous material 15.Alternatively, viscous material 15 may be contained within sleeve 13such that it may flow freely within sleeve 13 and between elastic band 9and substantially non-extendable band 11.

The structure and design of visco-hyperelastic composite band 5 providesmotion of the band 5 that mimics the non-linear visco-hyperelasticbiomechanics of the connective tissue surrounding the cervical spine,enabling stable unconstrained movement within a normal functional rangeof motion. Composite bands 5 also provide increased support andstability for the cervical spine at the extreme positions within thenormal range of motion and generate resistance to movement of thecervical spine beyond the normal functional range of motion for aparticular wearer. Similar to an individual's natural biological system,composite band 5 provides low stiffness at low stretch ratios. Thestiffness of band 5 then increases exponentially as the stretch ratioincreases.

Since an individual's functional range of motion is highly dependentupon the speed of loading, composite band 5 is designed to account forvariations in loading rates by comparatively decreasing the allowedrange of motion at high loading rates relative to allowed range ofmotion at lower loading rates. Furthermore, visco-hyperelastic compositeband 5 may also help maintain the head in a neutral, upright positionthat supports the natural lordotic curve of the cervical spine,assisting the wearer in supporting heavy helmets 1 and/or facemasks aswell as acting to prevent the head from assuming an extreme positionwithin the natural range of motion. Therefore, cervical spine protectionapparatus 100 substantially protects a user from spinal injuries withoutsubstantially compromising the user's normal functional range of motionand by minimizing the magnitude of forces applied to the neck andcervical spine by helping to maintain the head in a neutral, upright andrelaxed position.

FIGS. 2(a)-2(b) illustrates the operation of visco-hyperelasticcomposite band 5. At rest, substantially non-extendable band 11 mayassume a natural waveform configuration, wherein no stress is applied bysubstantially non-extendable band 11 to elastic band 9. As band 5 isstretched, elastic band 9 is held in tension and substantiallynon-extendable band 11 begins to straighten as both bands lengthen. Inthis initial stretched state wherein elastic band 9 is under tension andsubstantially non-extendable band 11 is not yet fully extended from itsinitial folded state, the combination of elastic band 9 andsubstantially non-extendable band 11 offers a relatively low resistanceto movement. Only the resistance of elastic band 9 is functionallyengaged at these low stretch ratios or low applied loads.

As composite band 5 approaches full extension, resistance substantiallyincreases due to the fact that substantially non-extendable band 11 isextended to its full length at which point it becomes non-extendable andoffers significant resistance to further movement. Thus, substantiallynon-extendable band 11 may be used to prevent the user's cervical spinefrom assuming injurious positions beyond the normal functional range ofmotion. At these high stretch ratios or high applied loads,substantially non-extendable band 11 becomes substantially engaged,substantially increasing the total resistance of composite band 5.Preferably, composite band 5 is adjusted such that substantiallynon-extendable band 11 becomes fully extended and straightened when thewearer assumes a position at an extreme of the normal functional rangeof motion. At this point, visco-hyperelastic composite band 5 becomesseveral times stiffer than the stiffness of elastic band 9 and generatessignificant resistance to further motion of the cervical spine.

In embodiments including viscous material 15, viscous material 15provides the additional benefit of adjusting the resistance offered bycomposite band 5 relative to the applied loading rate. Thus, as the rateof loading increases, the amount of resistance offered by the viscousmaterial 15 of composite band 5 also increases. Therefore, this aspectof the visco-hyper elastic composite band 5 of the present inventionprovides additional protection for the cervical spine in the case ofhigh loading rates such as may be encountered during high speed impact.However, viscous material 15 does not substantially alter the resistanceprovided by elastic band 9 and substantially non-extendable band 11during lower loading rates.

In an exemplary embodiment, two or more, preferably, four or morevisco-hyperelastic composite bands 5 may be used to connect helmet 1 andbrace 3 to provide multi-directional protection and reduce the riskand/or severity of incurring cervical spine injuries due to varioustypes of loading and/or impact forces. Visco-hyperelastic compositebands 5 may be arranged in a network or matrix that restricts cervicalspine movement to within an optimal or normal range of motion in one ormore directions. As shown in the exemplary embodiment of FIGS. 1(b), (e)and (f), four composite bands 5 may be positioned and attached to theposterior region of helmet 1 and brace 3 or platform 7. Alternatively, adistal end of one or more composite band 5 may be positioned on a leftside, right side or posterior region of helmet 1 and the correspondingproximal end of one or more composite bands 5 may be attached to a leftside, right side or posterior region of brace 3 and/or platform 7.Composite bands 5 may be oriented in different directions relative toone another and oriented at different angles relative to an attachmentstructure. Depending upon the desired range of motion and degree ofresistance desired, composite bands 5 may or may not be arranged tocross paths with other composite bands 5. In an exemplary embodiment,composite bands 5 may be positioned to provide resistance to extensionand/or flexion of the cervical spine. Composite bands 5 may also bepositioned to provide resistance to lateral movement of the head or torotation of the spine or head about the axis of the spine. Combinationsof composite bands 5 may be employed to resist two or more of thesetypes of motion as well. Further, specific, different composite bands 5may be employed to resist motion in a particular direction. For example,a system of four bands may be employed to: (1) resist extension flexion,(2) resist lateral movement to the right, (3) resists lateral movementto the left, and (4) resist rotation about the longitudinal axis of thecervical spine.

Composite bands 5 may be integrally or removably attached to one or moreupper attachment structures 2, such as may be provided by or attached toa helmet 1, and/or one or more lower attachment structures 4, such asmay be provided by or attached to a brace 3, platform 7 or combinationsthereof. In one embodiment, helmet 1, brace 3 and platform 7 may includeone or more, preferably, two or more fasteners 17 that may facilitateremovable attachment of composite bands acting in concert with one ormore, preferably, two or more corresponding fastener 19 positioned on,through or in each composite band 5. Exemplary fasteners 17 andcorresponding fasteners 19 may include hooks, loops, snaps, threadedmeans, latches, notches, clasps, apertures, or combinations thereofsuitable for removably securing composite band 5 to helmet 1, brace 3,platform 7 or combinations thereof. Alternatively, composite band 5 maybe wrapped around, tied about, or may be held in place by a friction fitor form fit to a suitable fastener such as a snap 17, or combinationsthereof. Similarly, one or more devices providing upper and lowerattachment structures may be wrapped around, tied about, form a frictionfit or form fit to a suitable corresponding fastener such as a snap 19,or combinations thereof. As shown in FIGS. 1(a)-1(f), a plurality offasteners such as snaps 17 and corresponding fasteners such as snaps 19may be positioned on a surface of or within composite band 5, helmet 1,brace 3, platform 7 or combinations thereof in order to adjust the fitof cervical spine protection apparatus 100 to any user. In an exemplaryembodiment, multiple fasteners 17 may be arranged on a left side, rightside, posterior region or any combination thereof of helmet 1, brace 3and/or platform 7. A plurality of corresponding fasteners 19 may bearranged on a distal end, proximal end, or intermediate regiontherebetween of each composite band 5. Fasteners 17 and correspondingfasteners 19 enable a user to select attachment structures, arrange thelocation, adjust the length, arrange the orientation or a combinationthereof of composite band 5 in order to provide the desired range ofmotion which may be customized for the particular wearer. Alternatively,composite bands 5 may be integrally attached to helmet 1, brace 3,platform 7 or combinations thereof wherein cervical spine protectionapparatus 100 has been manufactured to fit a particular user or aparticular size of user.

The invention is also directed to a method for spinal stabilization thatinvolves using cervical spine protection apparatus 100 to reduce and/orminimize the risk and/or severity of incurring cervical spine injuries.Upon putting on cervical spine protection apparatus 100, an upperattachment structure 2, such as may be provided by or attached to helmet1, may be adjusted to ensure a secure fit with the user's head using anyconventional attachment mechanism; similarly, a lower attachmentstructure 4, such as may be provided by or attached to brace 3, may beadjusted to ensure that it is secured to the user. Composite bands 5 maybe attached to helmet 1 and brace 3 and/or platform 7. In the method,one or more of the placement, length and orientation of composite bands5 may be adjusted for the particular wearer to provide resistance toparticular types of movement and/or forces, to customize the apparatusto the user's functional range of motion and to compensate for thepossibility of high loading rates in high impact activities such astackle football.

In an exemplary embodiment, the arrangement of composite bands 5 may bedictated by a computer program stored on a computer readable medium. Thecomputer program may run on a specialized medical diagnostic computerincluding suitable hardware or software specially designed for medicalpurposes or alternatively, any conventional computer. Upon inputtingvarious factors, conditions, dimensions, or combinations thereofassociated with an intended user and/or application, the program mayrecommend the number, position, orientation and/or lengths of compositebands 5 to be used. In an exemplary embodiment, the computer program mayconsider the gender, overall weight, head size, head mass, neck size,neck strength and musculature, shoulders size, shoulder musculature,cervical spine morphology, desired range of motion of the cervicalspine, intended activity, intended applied force, previous injuries tothe connective tissue of the cervical spine, previous injuries to thecervical spine, helmet size, helmet weight, center of gravity, orcombinations thereof when determining the number, positions,orientations and/or lengths of composite bands 5. One or more compositebands 5 may then be attached to helmet 1, brace 3, platform 7 orcombination thereof using fasteners 17 and complementary fasteners 19.This ability to adjust cervical spine protection apparatus 100 allowsthe invention to accommodate for variations between individuals and/ortypes of activity and provides an effective apparatus that may be usedto safeguard the cervical spines of adults as well as that of developingchildren and adolescents.

In an exemplary embodiment, cervical spine protection apparatus 100 maybe used to safeguard and reduce the risk of injuring the cervical spineor the severity of such injuries during any sporting, occupational orrecreational activity. In an exemplary embodiment, it may be used tosafeguard and reduce the risk and/or severity of cervical spine injuryfor participants of high impact sports or recreational activities, suchas football, hockey, baseball, biking, mountain climbing, skiing andskateboarding. In an exemplary embodiment, the invention may be designedto particularly protect the user from or minimize the risk and/orseverity of various multidirectional cervical spine injuries due toinjurious movement such as, hyperextension, rotational hyperextension,lateral overextension, flexion, or combinations thereof, withoutinterfering with athletic performance. In an exemplary embodiment,cervical spine protection apparatus 100 may substantially prevent orminimize the risk of assuming an injurious position in two or moredifferent directions or two or more different types of motions,preferably substantially prevent or minimize the risk of assuming aninjurious position in three or even four or more different directions orthree or four or more different types of motions.

The invention is also directed to a method for using cervical spineprotection apparatus 100 of the present invention to facilitate therehabilitation of any injuries to or deformities of the cervical spine.In an exemplary embodiment, upper attachment structure 2 may be attachedto or provided by a conventional hat or scaffold, and lower attachmentstructure 4 may be attached to or provided by any back brace or neckbrace. Upon placing the cervical spine protection apparatus 100 on anindividual who has suffered a cervical spine injury or suffers from acervical spine deformity, apparatus 100 may be adjusted in the samemanner as described above. The individual may then participate insupervised physical therapy exercises. Cervical spine protectionapparatus 100 may also enable the user to perform physical therapyexercises without supervision while ensuring that the user does notassume a position that would further exacerbate the injury. In anexemplary embodiment, cervical spine protection apparatus 100 may beparticularly useful for individuals who have suffered a cervical spineinjury prone to recurrence, such as cervical cord neurapraxia. Cervicalspine protection apparatus 100 may be used to facilitate healing andprevent and minimize the risk of reinjuring the cervical spine.

EXAMPLES Example 1

An exemplary embodiment of the cervical spine protection apparatus 100of the present invention was constructed and evaluated to determine itsbiomechanical capabilities. As shown in FIGS. 1(a)-1(f), the cervicalspine protection apparatus 100 was attached to a standard footballhelmet 1 and a brace 3 configured as conventional football shoulder padshaving a platform 7. Visco-hyper elastic composite bands 5 of apparatus100 were made from an elastic band 9 stitched to a substantiallynon-extendable band 11 constructed from stiff canvas cloth. A viscoussilly putty material 15, filled the interior cavity formed betweenelastic band 9 and substantially non-extendable band 11. Fourvisco-hyper elastic composite bands 5 were removably secured with snapsbetween football helmet 1 and shoulder pads 3. As shown in FIG.3(a)-3(b), strain-gage torque sensors were mounted to football helmet 1to measure the sagittal plane dynamics, and positional, transitional androtational sensors were also mounted to shoulder pads 3 to measureacceleration, velocity and position of the user's head and torso.

Two experiments were conducted on two individuals while wearing cervicalspine protection apparatus 100. Using a Neck Flexible Tester (NFT), thequasi-static passive and active mechanical properties of cervical spineprotection apparatus 100, including the passive and active range ofmotion, coupled range of motion, load-displacement/flexibilitycharacteristics and isometric muscle strength (IMS), which predicts theapplied maximal active torque, were evaluated. The NFT was designed toaccommodate large test subjects wearing football gear and thus wasconstructed from strong materials and large structural elements thatenabled the linkages to withstand the large torques generated by thetest subject's neck musculature during IMS testing.

In the first experiment, the test subjects were fitted with a helmet,football shoulder pads and a cervical spine protection apparatus 100 andsubsequently positioned within the NFT, shown in FIGS. 2(a)-(b), todetermine cervical spine stabilization and the degree of interferencewith the user's normal cervical spine range of motion. Designed usingthe Grood and Suntay anatomical coordinate system (J. Biomech. Eng. 105(1983) 136), the NFT is a unique six-degrees-of-freedom instrument thatcan measure the rotational and translational motion of the cervicalspine produced either voluntarily by a user or in response to externalloads applied by an examiner. The applied torque and resulting motionwere measured using strain-gage torque sensors and positional rotationaland translational sensors mounted on three axes of the linkage. As shownin FIGS. 2(a)-(b), one end of an NFT linkage was fixed to a chairsupporting the test subject, and the other end of the linkage was fixedto the head through either a lightweight test helmet or football helmet1. Sitting in the NFT chair, the test subject's lumbar spine andscapulae were supported by the back of the chair and the test subject'spelvis was stabilized with a waist belt while the upper thoracic area,i.e. the base of the cervical spine, was stabilized using a paddedbreast plate. The axes of the NFT are adjustable so they could bealigned with the user's specific anatomy. In this experiment, the axisfixed to the chair, corresponding to the axis for lateral bending of thecervical spine, was adjusted to align with the first thoracic vertebrae.Specifically, the spinous process of the T1 and one axis of the linkagewas adjusted to align with T1. With the head level, the axis fixed tothe helmet, corresponding to the axial rotation, was adjusted so that itwas perpendicular to the Frankfurt horizontal plane, and the helmet wasthen attached to the NFT. A third floating axis of the NFT did notrequire any adjustment as it aligned naturally to provide a measurementof cervical spine flexion and extension. Each axis of the linkage wasdesigned to have a specially constructed combination of linear andangular precision potentiometers to measure the angular and lineardisplacement of the cervical spine about and along each axis. To measureisometric muscle generated torques, strain-gauge torque sensors weremounted permanently on each axis of the linkage. To provide fixationduring the IMS testing and coupled range of motion testing, wherein thecervical spine was fixed in one position, such as in extension, whileconducting a range of motion test in a given direction, such as lateralbending, each rotational degree of freedom in the NFT was provided witha lock so that the cervical spine could be positioned and fixed in anydesired position. A hexagon structure was machined at the end of eachaxis so that a socket wrench instrumented with a strain-gage torquesensor could be used to manually apply and measure torques around eachaxis. Voltage outputs from the potentiometers and the torque sensorswere fed into an analog-to-digital converter and stored on a computer.

The active and passive range of motion and the IMS were measured in alldirections when the test subjects were: (1) in their football gear, (2)wearing helmet 1 including a cervical spine protection apparatus inaccordance with the present invention and (3) out of their football gearwearing only a light helmet fixed by the NFT. The active range of motionwas measured by instructing the test subject to move his head inflexion, extension, lateral bending and axial rotation to the point ofreaching the limits of the range of motion. Passive range of motion andpassive load-displacement characteristics were measured by instructingthe test subject to relax and then applying a force to the testsubject's head. Specifically, the test subject's head was manually movedin slow cyclic movements in all directions. The applied torque wasmeasured using a torque sensor. Passive limitation of motion, defined asthe maximum range comfortably tolerated by the subject, was achieved.IMS estimates were then obtained by instructing the test subject toapply a maximal force in resisting the external cyclic movement. Thepassive range of motion and load-displacement characteristics were thenmeasured using a torque sensor.

As shown in FIG. 5, the test results for the passive and active rangesof motion with and without the football gear revealed that, as expected,the passive range of motion was larger or equal to the active range ofmotion. Additionally, the football gear significantly limited the rangeof motion of the cervical spine in lateral bending by 46%. The resultsdemonstrate that apparatus 100 provides multi-directional neckprotection without interference with the required functional motion.

In the second experiment, the effect of cervical spine protectionapparatus 100 on the dynamics of the cervical spine was evaluated whilethe test subjects ran on a treadmill at a steady pace of about 1.8 m/s.During the first part of this experiment, each test subject fixatedcontinuously on a visual target at about 3 m distance. In the secondpart of the experiment, the test subjects ran in the dark. In bothscenarios, the test subjects were asked to maintain the head in acomfortable position, facing forward.

To measure the effect of standard football gear and cervical spineprotection apparatus 100 on cervical spine dynamic motion in thesagittal plane, sensors that combined a three-axis accelerometer and athree-axis rotational velocity sensor (ADIS16350, Analog Devices,Norwood Mass.) were mounted to the test subject's torso and helmet.Large displacement, indium gallium, strain gages (Hokanson, BellevueWash.) were attached from the back of each helmet to the top of thesubject's shoulder pads to track head position relative to the trunk.Data was collected using a tablet PC (Motion Computing, Austin Tex.)which was held securely in a backpack worn by the subjects. Testing wasconducted under three experimental conditions, wherein the test subjectswore: (1) a lightweight helmet (Petzl Meteor III) only and no shoulderpads; (2) a football helmet (Adams Y-Three) and shoulder pads; and (3) acustom-made cervical spine protection apparatus 100 attached between afootball helmet and shoulder pads.

FIG. 6 demonstrates that the football gear pulled the neck into flexion,and that cervical spine protection apparatus 100 positioned between thefootball helmet and shoulder pads was able to compensate for the weightof a conventional football helmet by pulling the neck and head back intoa more natural position and by reducing the neck's angular displacementwhile the test subject ran. When wearing the lightweight helmet of theNFT, the test subject's head was held back at an angle of about 3.9degrees relative to the trunk; when running, the angular excursion ofthe head was positioned at about a root mean square (RMS) value of 2.7degrees. The head extended back by as much about 13.0 degrees during theexperimental trials and was never measured to move more than about 4.1degrees into flexion. The excursion of the head was similar when thefootball helmet and facemask were worn, but instead of being centeredabout an average position of about 3.9 degrees, the position was shiftedforward to an average of about 1.0 degree of flexion (RMS 2.7 degrees)and reached as far as about 10.2 degrees into flexion. Cervical spineprotection apparatus 100 pulled the head back into extension and reducedthe magnitude of the neck's angular motion. The average position of thehead was about 1.5 degrees, and the RMS value of the movement wasreduced to 1.7 degrees. Results were similar regardless of whether thetest subject fixated on a visual target or was tested in the dark.

Accompanying the significant alterations to the position of the head andneck due to the presence of a helmet were changes to the amplitude ofthe acceleration and velocity of the torso, head and cervical spine. Inall cases, however, the predominant frequency of the signals occurrednear 3.0 Hz in the sagittal plane (1.5 Hz in yaw) which corresponds tothe frequency of the runner's foot strike. Because of the additionalmass of the football helmet, the linear acceleration and rotationalvelocity of the head was lower when wearing the football helmet thanwithout the football helmet. For example, the RMS values of the head'slinear acceleration along the x axis (posterior-anterior) decreasedapproximately 50% from 4.0 m/s² when the lightweight helmet was worn toabout 2.1 m/s² when the cervical spine protection apparatus 100 wasworn. Consistent with decreases in sagittal plane acceleration, the RMSrotational velocity of the head in pitch decreased from about 37.5 deg/swith the lightweight helmet to about 28.1 deg/s with the footballhelmet, and further to about 20.1 deg/s with the cervical spineprotection apparatus 100.

The football helmet impacted the dynamics of the torso as well, despitethe fact that the test subject ran on a treadmill at the same speed foreach experimental trial. Most interesting was how linear accelerationsalong the x-axis were affected, as shown in FIGS. 7(a)-(b). Thefrequency content of the linear accelerations was substantially the samewhenever the test subject wore the football helmet. Like footballhelmets, power for the lightweight helmet was concentrated at thefrequency of the foot strike (3.2 Hz) but its spectrum indicated thatthere was also significant power at harmonic frequencies. In contrast tothe frequency spectrum, the amplitude distribution for the subjectswearing the lightweight helmet; football helmet; and cervical spineprotection apparatus 100 attached to a football helmet and shoulder padswere much the same, whereas the amplitude distribution for the footballhelmet alone was different.

The RMS linear acceleration of the trunk doubled from 0.9 m/s² for thelightweight helmet and from 1.0 m/s² for the cervical spine protectionapparatus 100 to 2.1 m/s² for the football helmet. This may beattributable to a change in gait that was caused by the football helmetpulling the head and neck forward, and which was corrected by cervicalspine protection apparatus 100. As with the head, the RMS rotationalvelocity of the torso in pitch decreased when the football helmet wasworn; from about 85.6 deg/s without the helmet to approximately 45.0deg/s whenever the football helmet was worn. The changes in theaccelerations and velocities of the torso and head caused large changesto the resultant sagittal plane velocity of the cervical spine. Themagnitudes of the velocities were largest when the subject wore thelightweight helmet (RMS 136.5 deg/s), much smaller when the footballhelmet was worn (RMS 76.8 deg/s), and smaller still when cervical spineprotection apparatus 100 was worn (RMS 66.0 deg/s). As shown in FIG. 8,the smaller rotational velocities of the head and cervical spine whenthe football helmet was worn did not result in smaller angulardisplacements of the cervical spine. The angular displacement of thecervical spine in the sagittal plane was only reduced when cervicalspine protection apparatus 100 was worn. Results were similar whetherthe subject fixated on a visual target or was tested in the dark.Overall, cervical spine protection apparatus 100 exceeded performanceexpectations, maintaining the neck in an erect posture during runningand delayed the onset of neck muscle fatigue.

Example 2

In this computer model study, the difference in the response of apediatric cervical spine to external loads in comparison to an adultcervical spine, both without and with cervical spine protectionapparatus 100, were evaluated. Numerical models of a standard Hybrid III6-year-old dummy and the standard Hybrid III 50^(th) percentile maledummy were used in simulations conducted using the MADYMO software [TNO,2004]. These dummies, and similar anthropometric models, are widely usedin the automotive and aviation industry for injury risk assessment.Virtual sensors were used to measure the three dimensional linearacceleration of the head and the resultant forces and moments in theupper (at the C1 level) and lower (at the C7 level) cervical spine.FIGS. 9(a)-(g) illustrate the initial setup for the models with noprotection, with regular football gear and with cervical spineprotection apparatus 100 attached between a football helmet and shoulderpads.

In these simulations, the dummy's head was subject to impactaccelerations recorded experimentally on adult tackle football players[Viano, 2005b]. The upper and lower cervical spine force and moment forwhich are illustrated in FIGS. 10(a)-(b), and the resultant quantitativedynamics, including cervical spine motion, are shown in Table 1 below.The results demonstrate differences between the response of the child'scervical spine from that of an adult as well as the restraining effectof cervical spine protection apparatus 100, which was confirmedexperimentally.

TABLE 1 Output parameters produced in the various models in response toan experimental impact acceleration profile. Upper Neck Lower Neck DummyProtection Head Acceleration Resultant Torque Resultant Torque TypeCondition (m/sec{circumflex over ( )}2) Force (N) (Nm) Force (N) (Nm)Hybrid III No protection 142 1610 72 1450 60 6 year old With standard165 2106 94 1980 81 child protection dummy With CSPD 142 1724 64 1502 48Hybrid III No protection 87 410 38 451 58 Adult With standard 93 800 44884 71 male protection dummy With CSPD 75 350 20 415 50

Example 3

FIG. 11 shows the results of a tensile test conducted on an exemplaryvisco-hyperelastic composite band 5 at two different loading rates. Thecomposite band 5 included a elastic band 9 stitched to a substantiallynon-extendable band 11 constructed from stiff canvas cloth. A viscoussilly putty material 15 filled the interior cavity formed betweenelastic band 9 and substantially non-extendable band 11. FIG. 11demonstrates that the stiffness of composite band 5 increases dependenton the loading rate of said composite band 5.

Example 4

The affect of cervical spine protection apparatus 100 on the positionand orientation of a user's cervical spine was also examined. FIG. 12(a)shows the natural head posture of an individual wearing football gear.FIG. 12(b) shows the natural head posture of an individual wearingcervical spine protection apparatus 100 attached to a football helmetand shoulder pads. The visco-hyper elastic composite band 5 of cervicalspine protection apparatus 100 functions to support the natural lordoticcurve of the cervical spine and aid the neck muscles in supporting theweight of a helmet so that the neck does not move into the flexedposture of FIG. 12(a). FIGS. 12(c)-12(d) compare the MRI images of anindividual wearing a football helmet and shoulder pad and the sameindividual wearing cervical spine protection apparatus 100 attachedtherebetween, respectively. The MRI images demonstrate the cervicalspine protection apparatus 100 prevents the undesirable flexed restingposture in which the cervical spine is axially aligned. Rather, theinvention assists the user in maintaining an upright posture withnatural lordosis, wherein the neck is curved naturally so forces can beabsorbed by musculature rather than by straining ligaments or beingtransmitted along vertebral bodies.

The foregoing description of the invention has been presented for thepurpose of illustration and description only and is not to be construedas limiting the scope of the invention in any way. The scope of theinvention is to be determined from the claims appended hereto.

The invention claimed is:
 1. A protection apparatus for wearing by aperson for reducing risk of cervical spine injuries, comprising (a) anupper attachment structure for wearing on a person's head; (b) a lowerattachment structure for wearing on a person's body below the head; and(c) a plurality of composite bands connected between the upperattachment structure and the lower attachment structure for dynamicallylimiting motion of the cervical spine to functional and non-injuriousmotion; (d) wherein each composite band provides non-linear variableflexibility that is dependent upon variations in loading rates; and (e)wherein each composite band comprises, (i) an elastic componentcomprising an elastic or spring-like material for providing elasticityof the composite band, (ii) a substantially non-extendable componentattached to the elastic component, the substantially non-extendablecomponent comprising a substantially non-extendable material, and (iii)a viscous material contained in an area between the elastic componentand the substantially non-extendable component.
 2. The apparatus ofclaim 1, wherein each composite band has a cylindrical configuration. 3.The apparatus of claim 1, wherein the viscous material of each compositeband is contained within a sleeve.
 4. The apparatus of claim 1, whereinthe viscous material of each composite band has a viscosity of about 150cP to about 100,000 cP.
 5. The apparatus of claim 1, wherein the viscousmaterial of each composite band comprises a non-solid material.
 6. Theapparatus of claim 1, wherein the viscous material of each compositeband comprises a gel.
 7. The apparatus of claim 1, wherein the viscousmaterial of each composite band has a viscosity similar to oil.
 8. Theapparatus of claim 1, wherein the viscous material of each compositeband comprises a solid material.
 9. The apparatus of claim 1, whereinthe viscous material of each composite band comprises a putty.
 10. Theapparatus of claim 1, wherein the elastic material of each compositeband comprises polymers.
 11. The apparatus of claim 1, wherein theelastic material of each composite band comprises rubber.
 12. Theapparatus of claim 1, wherein the elastic component of each compositeband has a modulus of elasticity of about 20 psi to about 30,000 psi.13. The apparatus of claim 1, wherein the substantially non-extendablematerial of the substantially non-extendable component of each compositeband comprises a metal.
 14. The apparatus of claim 1, wherein thesubstantially non-extendable component of each composite band has amodulus of elasticity of about 400,000 psi to about 7,500,000 psi. 15.The apparatus of claim 1, wherein the substantially non-extendablecomponent in each composite band is attached to the elastic componentthereof by stitching, adhesive, heat fusion, or a combination thereof.16. The protection apparatus of claim 1, wherein at least one of thecomposite bands is removably attachable to the upper attachmentstructure.
 17. The protection apparatus of claim 1, wherein at least oneof the composite bands is removably attachable to the lower attachmentstructure.
 18. The protection apparatus of claim 1, wherein the spinalprotection apparatus is at least part of protective sports or athleticgear.
 19. A spinal protection apparatus, comprising (a) an upperattachment structure for wearing on a person's head; (b) a lowerattachment structure for wearing on a person's body below the head; and(c) a plurality of composite bands connected between the upperattachment structure and the lower attachment structure; (d) whereineach composite band provides non-linear variable flexibility that isdependent upon variations in loading rates; and (e) wherein eachcomposite band comprises, (i) an elastic component comprising an elasticor spring like material for providing elasticity of the composite band,(ii) a substantially non-extendable component attached to the elasticcomponent, the substantially non-extendable component comprising asubstantially non-extendable material, and (iii) a viscous materialcontained in an area between the elastic component and the substantiallynon-extendable component.
 20. A method for spinal stabilization,comprising a step of: attaching at least one composite band havingnon-linear variable flexibility that is dependent upon variations inloading rates to first and second attachment structures located atdifferent positions along a spine in a manner for dynamically limitingmotion of the cervical spine to functional and non-injurious motion, thecomposite band comprising, (i) an elastic component comprising anelastic or spring like material for providing elasticity of thecomposite band, (ii) a substantially non-extendable component attachedto the elastic component, the substantially non-extendable componentcomprising a substantially non-extendable material, and (iii) a viscousmaterial contained in an area between the elastic component and thesubstantially non-extendable component.